Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

NCT00831376 | Completed Phase 4

• 1 other identifier: NAI009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the relative bronchoprotection (at trough) conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to moderate asthmatics. Patients will be preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a differential effect on the bronchoprotection conferred by both formulations of salbutamol, as evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any effect can be explained by the S enantiomer in the racemic formulation.

Conditions

Asthma

Keywords

Asthma; Genotype; Beta2adrenoreceptor; Levosalbutamol

Outcome Measures

Primary Outcomes (1)

• methacholine challenge

  before and after 2 week study period

Secondary Outcomes (4)

• spirometry

  before and after 2 week study period

• nitric oxide levels

  before and after 2 week study period

• symptom scores

  before and after 2 week study period

• Bmax and Emax

  before and after 2 week study period

Study Arms (3)

levosalbutamol

EXPERIMENTAL

Patients will be asked to take two puffs four times a day for 2 weeks

Drug: levosalbutamol

2: racemic salbutamol

ACTIVE COMPARATOR

Patients will be asked to take two puffs four times a day for 2 weeks

Drug: racemic salbutamol

3: Placebo

PLACEBO COMPARATOR

Patients will be asked to take two puffs four times a day for 2 weeks

Drug: placebo

Interventions

levosalbutamol DRUG

Patients will be asked to take two puffs four times a day for 2 weeks

levosalbutamol

racemic salbutamol DRUG

Patients will be asked to take two puffs four times a day for 2 weeks

Also known as: Ventolin

2: racemic salbutamol

placebo DRUG

Patients will be asked to take two puffs four times a day for 2 weeks

3: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent, who are methacholine responsive PC20\< 4 mg/ml
• \>1dd change in methacholine PC20 after the administration of racemic Salbutamol.
• Male or female 18-65
• Informed Consent
• Ability to comply with the requirements of the protocol

You may not qualify if:

• Severe asthmatics as defined by an FEV1≤ 60% or PEF variability \> 30% or with continual daytime or nocturnal symptoms.
• The use of oral corticosteroids within the last 3 months.
• Recent respiratory tract infection (2 months).
• Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
• Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA, that may endanger the health or safety of the participant, or jeopardise the protocol.
• Any significant abnormal laboratory result as deemed by the investigators
• Pregnancy, planned pregnancy or lactation
• Known or suspected contra-indication to any of the IMP's
• Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Asthma and Allergy Research Group

Dundee, Angus, DD1 9SY, United Kingdom

Location

Related Publications (1)

• Anderson WJ, Short PM, Williamson PA, Morrison AE, Palmer C, Tavendale R, Lipworth BJ. Proof-of-concept evaluation of trough airway hyper-responsiveness following regular racemic or levosalbutamol in genotype-stratified steroid-treated persistent asthmatic patients. Clin Sci (Lond). 2014 Jan 1;126(1):75-83. doi: 10.1042/CS20130213.

  PMID: 23829494 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Karine L Clearie, MBBS, MRCP

  Asthma and Allergy Research Group

  PRINCIPAL INVESTIGATOR

• Brian J Lipworth, MBchB

  Asthma and Allergy Research Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

GB (1)